HPV vaccines were initially licensed in 2006, aimed at preventing high-risk strains of HPV, strains that can cause cancer or genital warts. For a variety of reasons, uptake of HPV vaccines remains low in the United States. Several states have undertaken efforts to improve uptake, using a variety of policy mechanisms, to improve uptake.

In response, several persons or group, many of which (though not all) can be fairly described as anti-vaccine, have made a series of claims about HPV vaccines, claiming the efforts were unjustified on policy grounds and the vaccines unsafe and/or unnecessary.

This post addresses those claims with referenced, science-based information, explaining why the policy efforts to improve HPV uptake are well-founded, and the arguments against them either inaccurate or unconvincing.

Importance and Effectiveness:

HPV infections are very common, and cause substantial harms and deaths. Increasing vaccine uptake can reduce those harms, and is a legitimate, well-justified public health goal.

HPV infections cause tens of thousands of cancers and thousands of deaths each year. HPV vaccines can prevent the vast majority of that cancer. The lifetime risk for women for one of these cancers – cervical cancer alone – is 1:161. Low uptake, therefore, which leaves a risk of many cancers and deaths, can fairly be described as a public health crisis.

There is increasing evidence that the vaccine reduces HPV infections with cancer-causing strains. The evidence comes from studies in the UnitedStates, in Australia, and in Scotland. While it is too early to see the effect on cancer rates just yet, the reduction in infection, and dramatic reductions in precancerous lesions, are strong evidence that the vaccine is working as expected. In other words, if a person isn’t infected, they cannot develop precancerous lesions; preventing precancerous lesions means the vaccinated person doesn’t go on to develop cancer.

The vaccine has been shown to be safe even for people who are infected with the HPV vaccine at the time of vaccination. However, some people who are opposed to the HPV vaccine claim such people have a higher risk of developing cancer, citing the outcomes for one subgroup in one clinical trial. This fear was addressed at the May 2006 meeting of the FDA body that oversees the safety of vaccines, the Vaccines and Related Biological Products Advisory Committee. To paraphrase the report prepared for the meeting the subgroup that showed a higher risk in the pre-2006 trials had other enhanced risk factor developing cancers, compared to the subjects who received placebo. Other subgroups in the study did not have larger numbers of subgroups that developed cervical disease. A later, larger study of over 17,000 women showed that women receiving the HPV vaccine after being infected with HPV did not have a higher risk of developing cancer.

The vaccine does not increase the risk for later cervical disease. Some anti-vaccine activists claim that “girls who received the four strain HPV shot, when assessed 10 years later, were actually more likely to be infected with high risk, low risk, and all strains of HPV. The four vaccine strains were reduced– but other, possibly more pathogenic, HPV viruses moved in to fill the void.”. This is the “replacement risk” argument. This claim cites a 2015 poster presentation, which was later published in Human Vaccines & Immunotherapeutics. The published article actually says the difference between vaccinated and non-vaccinated women was much reduced after adjusting for sexual behavior variables, and that women who were vaccinated early with the four-serotype vaccine may benefit from the newer, nine-serotype vaccine. Further, later studies did not find type replacement. In short, the “replacement risk” phenomenon alleged is not borne out by current research.

Safety:

The data showing HPV vaccines safe is abundant. A recent review found that with studies in over 2 million people, and data from 70 countries, no real safety concerns were found related to HPV vaccines. If readers would like a complete list of HPV vaccine safety studies, this site summarizes the safety data on HPV vaccines with links to the studies

Addressing Common Themes Repeated by Opponents of the HPV Vaccine to Challenge this Data:

Complaints About “No True Placebo Testing” and the Types Of Placebo Used in Trial

Several anti-vaccine activists are troubled by the fact that the control used in the trials for Gardasil was a solution containing the other vaccine ingredients, including AAHS, an aluminum salt adjuvant used for decades in infant vaccines like hepatitis B and others. These issues were specifically addressed by a vaccinologist in a recent article, which is quoted here at some length:

“The placebo effect

The key objective of a placebo is to allow the participant to believe they have received the medicine being tested. In the case of an injectable vaccine the most common reaction is injection site pain, sometimes with minor redness and swelling. Often, the added adjuvant (immune enhancer) can be the main cause of the reaction and it is just doing its job. From a vaccinology perspective a mild to moderate injection site reaction is generally a good thing.

….

The role of the antigen

Another factor in placebo selection is the importance of understanding the role of the active ingredient (antigen or antibody generator). What difference to the reactogenicity and safety profile does the addition of the active ingredient play?

Many vaccine developers prefer to balance the safety profile (identified in the trial) by ensuring the products in the vaccine carrier are present in both the active and placebo products. This means both the active and placebo study arm should both have the same local reaction to the impurities and other ingredients such as buffers and adjuvants. Any additional reaction rates will be related to the active ingredient.

…

Anyway, the choice of vaccine formulation minus the active ingredient as a placebo provides important data about the role of the active ingredient, which is the new kid on the block. Its behaviour when administered alone (without adjuvant in earlier phase studies) and in the full formulation is important.

Using the vaccine formulation mix minus the active ingredient is a normal practice in vaccine trials for the reasons outline above. For example, of three trials from different manufacturers for the same type of vaccine I am aware of, one used an adjuvant in the active formulation, and the adjuvant was not included in the placebo. Two of the three used the vaccine formulation mix in the placebo; the other trial used just saline as the placebo.”

The use of AAHS (an aluminum salt adjuvant) in placebo trials is an industry standard in vaccine trials where adjuvants are used, including previous HPV vaccine trials. The use of AAHS in the control arm of the Gardasil trials was clearly stated. Nonetheless, in one instance, an anti-vaccine activist suggested that the use of an AAHS solution in Gardasil trials was “fraud”, because the control wing of the trial was not “completely inert”. This claim is baseless. The researchers did not conceal or mislead; the difference between the active wing and the placebo wing of the trials were clear. The charged language is troubling, and should be considered as reflective of the frame of mind of those making the allegation.

Deaths Of Subjects During the Study Period

The sad fact is that children and adults do die, from accidents or diseases. In large-scale studies of any medication, even for healthy children and adults, there are always deaths in the study populations which are unrelated to the medication being studied. With respect to the HPV vaccine trials, anti-vaccine activists make much of the fact some subjects died during the study period, as described in the product insert. What they ignore or hide is that (1) the deaths were roughly equivalent in the vaccine group and the control groups, and (2) the deaths were for causes completely unrelated to vaccines. [1] Obviously, gunshot wounds, tuberculosis, and the other causes of death cited in the insert as cannot be attributed to the vaccine or to an injection containing tiny amounts of aluminum salts.

While one anti-vaccine source claimed the death rates were higher than the average in the population, they provided no direct source for that claim, which can therefore not be verified and cannot be assumed correct.

Among the deaths reported in the produce insert – deaths occurring during the trial – were deaths from suicide and drug overdose. Both are tragic, but these are different categories. The Gardasil insert, however, did not separate deaths by suicide from deaths from drug overdoses. One anti-vaccine source claimed the rate of suicide in the trial was too high compared to rates in the population. This rests on reports of 8 deaths: 2 received the vaccine, and 6 received an AAHS control. This claim is problematic in several ways:

Since the category in question is drug overdose/suicide a calculation comparing the members of the category to only suicide rates in the general rates of the population is simply wrong: it ignores drug overdoses.

No specific source was provided for the calculations of the rate of suicide in the population. They cannot, therefore, be verified – or relied upon.

Out of the 8 cases in these categories only two received the vaccine, and 6 received an AAHS control. First, this undermines the focus on the vaccine. Second, it is unconvincing to claim that a shot in the arm that contains tiny amounts of an aluminum adjuvants in amounts no greater than that given to infants would cause a health teen to commit suicide. The anti-vaccine sources offer no mechanisms by which that could happen, and it is implausible on its face.

Reliance on Adverse Effects Reporting Systems

There are several systems to report adverse effects of medications. One in the US is the Vaccine Adverse Effects Reporting System (VAERS). Anti-vaccine activists refer to reports made to adverse events reporting systems as evidence that the vaccine is dangerous. To use VAERS as evidence of vaccine dangers is a misuse of the system. VAERS accepts any report submitted to it, and without verification, those reports do not show causation. Further, in 2014 the CDC analyzed VAERS reports related to HPV vaccines and found no serious problems reflected in them.

Another reporting system is Vigibase, the international reporting system for case reports on all kinds of medication. Like VAERS, Vigibase warns against using the system to infer causation. These kinds of reports cannot establish causation.

There are studies with a small number of cases reporting that conditions such as Chronic Fatuige Syndrome (CFS), Postural Orthostatic Tachycardia Syndrome (POTS), and various autoimmune conditions occur after vaccination. Anti-vaccine activists use these studies to “prove” the dangers of vaccines, especially HPV. These small case studies, however, run against the largescale studies that looked at whether the vaccines caused these problems – and found they did not. See this site for summaries of and links to the studies.

In 2013, the Japanese government decided to withdraw the recommendation that Japanese girls receive the HPV vaccine. This decision came after a dubious study was made much of in the Japanese media, and after numerous startling media accounts of girls suffering a range of symptoms that the media linked to the HPV vaccine. The Vaccine Adverse Reactions Review Committee, a task force established by the Japanese Ministry of Health, Labor, and Welfare’s Health Science Council, has repeatedly concluded that no causal link exists between HPV vaccines and symptoms described in the media. The vaccine is still available in Japan to families that want to pay out of pocket for it. A study of 70,960 vaccinated and nonvaccinated adolescent girls from Nagoya also found no significant association between 24 alleged vaccine-induced symptoms and the HPV vaccines

There are several Japanese physicians who are still campaigning for re-approval of the vaccine. Nonetheless, anti-vaccine activists also point to Japan’s withdrawal of support for the HPV vaccine as proof of the vaccine’s dangers. Japan’s problematic decision is certainly not a reason for the United States to lessen its protection of its citizens.

In 2017, the Nordic Cochrane organization made a complaint to the European Ombudsman, claiming problems with HPV vaccines. Anti-vaccine activists exploit this complaint to prove the dangers of the HPV vaccine. However, the activists fail to mention that the complaint was rejected by the Ombudsman, which concluded: “There was no maladministration by the European Medicines Agency in the handling of the referral procedure on theHPV “

While the organization, allegedly, has complained about the Ombudsman’s decision, at this point, their complaint stands rejected, found baseless by the Ombudsman.

In short, extensive data shows HPV vaccines are safe. The counters raised by anti-vaccine activists are very, very weak.

[1] The most common cause of death was motor vehicle accident (5 individuals who received GARDASIL and 4 individuals who received AAHS control), followed by drug overdose/suicide (2 individuals who received GARDASIL and 6 individuals who received AAHS control), gunshot wound (1 individual who received GARDASIL and 3 individuals who received AAHS control), and pulmonary embolus/deep vein thrombosis (1 individual who received GARDASIL and 1 individual who received AAHS control). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, Correcting HPV Errors Letter-15kagff1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer in the group that received GARDASIL; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS control group; and 1 case of medulloblastoma in the saline placebo group.” https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm111263.pdf

Note: I shared this text as a letter after a request from people dealing with the anti-vaccine claims. I wanted to also publish it in a way that would be usable.

If the legislature did not require a show of sincerity for a religious exemption, several courts ruled that officials cannot demand a show of sincerity. In re LePage, 18 P.3d 1177, 1180 (Wyo. 2001); Dep’t of Health v. Curry, 722 So. 2d 874, 878–79 (Fla. Dist. Ct. App. 1998).

“Anti-vaccine activists have been claiming that statutes abolishing exemptions from school immunization requirements – like SB277 in California – are discriminatory. This post explains why this claim is wrong in both its form: school immunization requirements without exemptions are neither discrimination nor segregation.”

“In this post I explain how one goes about proving a case in the National Vaccine Injury Compensation Program (NVICP), and how that differs from proving a case in the civil courts, focusing on what it means to have a no-fault program and proving causation. I will use a case that started with the tragic death of a young child after a vaccine to illustrate the complexity and operation of the program, and also to address the idea of federal preemption, and how it limits the ability of those claiming vaccine injuries to use state courts for their claims. ”

“Two bills are currently proposed in California that may dramatically affect vaccination rates. Anti-vaccine activists have mobilized against them. We, the majority of vaccinating parents, need to do the same, speak up and make our preferences known. Say clearly that we will no longer have a preventable risk of disease forced on our children, ourselves, and other family members and friends by a minority. And we can. ”

“Several people have asked me whether having school mandates is in tension with the idea of informed consent. The answer is no. While school mandates have some effect on parental autonomy, the doctrine of informed consent should not be conflated with autonomy.

For a somewhat different reason, imposing sanctions on those who do not vaccinate is also not a violation of informed consent.”

This piece will explain why Holland and Zachary’s analysis is simply incorrect. And let’s be clear–there is a legitimate debate about whether school immunization mandates are appropriate, policy wise, as a response to non-vaccination.”http://www.skepticalraptor.com/skepticalraptorblog.php/yes-herd-immunity-works/

Full article: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2591591

“Abstract:

This article explains why claims made by Holland and Zachary in their article, Herd Immunity and Compulsory Childhood Vaccination: Does the Theory Justify the Law?, are incorrect and untenable. The authors misunderstand the nature of society’s duty to children, which is not similar to duty in torts but draws from the state’s role in protecting vulnerable children when their parents do not act in their best interests. Their view of herd immunity is also incorrect: the article does not well define the term, ignores data showing that herd immunity works, and their discussion of their two examples is inaccurate: close examination of those examples actually shows the role of herd immunity in protecting against disease. Finally, the authors’ analysis does not support their claim that mandates are unnecessary.”

“In reaction to the outbreak, politicians in many states proposed bills tightening exemptions from school immunization requirements.[10] This short article examines the law and legislative trends in this area.

…

Several states have exemption rates that are too high to preserve herd immunity. Oregon, at 7.1%, is at a high risk.[42] California has a low rate of exemptions overall, but has areas where rates of immunization are low.[43]Maine, Michigan, and Washington all have high exemption rates.[44] These states all face a real risk of disease. At least tightening these exemptions is a powerful idea.

Religious exemptions are completely inappropriate due to their vulnerability to abuse and the unfairness of putting the child at risk for beliefs the parents hold and the child is too young to choose. On the other hand, however, a system that does not leave parents any way to refuse vaccination is too extreme.

At the very least, since the public health argument is not as strong for homeschoolers, it makes sense to exempt children who are homeschooled from immunization requirements. Offering a hard-to-get personal belief exemption is preferable to a religious exemption, but should be harder to obtain than even the educational requirement currently in place. Ideally, getting the exemption would require a daylong course with a short quiz at its end. The course requirement would help limit exemptions to only the very small set of parents with the strongest feelings against vaccines, parents who believe that asking them to vaccinate is akin to asking them to poison their child.”

Lois A. Weithorn

In spite of vaccines’ impressive record of safety and effectiveness, some families have failed to immunize their children, denying those children protection against vaccine-preventable diseases. In the last years, rates of nonvaccination, as well as rates of partial adherence to vaccination schedules, have been increasing. Predictably, this has led to outbreaks of vaccine-preventable diseases. This article examines potential legal responses to this crisis. It sets out the legal framework governing childhood vaccination policies, highlighting the strength of governmental authority when the state’s police power to protect the public health and its parens patriae authority to protect the health of children and other vulnerable members of society converge, as they do in this context. After describing the phenomenon of nonvaccination, the reasons leading to parental refusals and the effects of those refusals, the article provides a menu of legal tools that can be used to improve vaccination rates.

At this point, no charges for manslaughter were filed against anyone. What we have is the start of an inquiry into the girl’s death, following a complaint by her parents. We do not know who, if anyone, will be charged with anything in connection to this.
A four-year-old daughter of wealthy, well-educated parents – no doubt a well nourished child – was left unvaccinated against measles, a preventable disease. Vaccination rates against it in Italy are around 90% for one dose of MMR and less than 85% for the second dose. As a result, cases are high in Italy: 3,943 reported cases in 2013 and 1,680 in 2014. MMR protects 95% of those that get one dose and 99% of those that get two doses (pdf). See the CDC information on MMR vaccine effectiveness. Those left unvaccinated – like little Clara was – are substantially more at risk of getting the disease. Clara did.
Little Clara got a generally fatal, horrible complication of the disease described by anti-vaccine activists as benign, mild or “a common childhood illness”.”

The Court of Appeal accepted the appeal filed by the Ministry of Health (ministero della Sanità). The expert appointed by the court of appeal highlighted that there is no scientific evidence supporting a link between vaccines and autism. The expert highlighted that the lower court expert was wrong to rely on the study by Andrew Wakefield, a study debunked and rejected by the scientific community.

The expert also highlighted that while there is some temporal link between Valentino’s MMR vaccine and autism, in the sense that the diagnosis of autism followed the vaccine, the temporal connection was not strong and does not itself support a causal connection.

The expert, Dr. Lodi, stated that “In the medical history of the child there is not an objective temporal correlation between the gradual emergence of autistic disorders and the MMR vaccine, there is only the fact that the two events occur one before the other, but as shown, this is not sufficient to relate the two events “.

The Bocca’s lawyer, Luca Ventaloro, claimed that he will appeal to the Supreme Court of Cassation (Corte Suprema di Cassazione), the highest court in Italy.”

“Several people have asked me whether having school mandates is in tension with the idea of informed consent. The answer is no. While school mandates have some effect on parental autonomy, the doctrine of informed consent should not be conflated with autonomy.

For a somewhat different reason, imposing sanctions on those who do not vaccinate is also not a violation of informed consent.”

First Do No Harm: Protecting Patients Through Immunizing Health Care Workers.

Dorit Rubinstein Reiss

University of California Hastings College of the Law

Rene F. Najera

John Hopkins University, Bloomberg School of Public HealthAbstract:

To protect vulnerable patients, hospitals increasingly adopt policies requiring health care workers to be vaccinated against influenza. More than twenty states have also enacted statutes or regulations on the topic. A small minority of health care workers oppose the requirement, and several have appealed to our courts of justice.
This article examines the legal issues surrounding influenza mandates for health care workers, including the constitutional framework, federal employment discrimination statutes, and the effect of collective bargaining. It argues that requiring vaccination for health care workers is both ethical and appropriate. While better done via state statute, hospitals have the authority to require vaccination from their workers – and are not, arguably, required to exempt any workers that do not have medical barriers to vaccination.

“On the 23 of September, 2014 a judge in the Labor Court of Milan awarded compensation (pdf, translated from Italian) to a child on the theory that the hexavalent vaccine manufactured by GSK – which protects children against polio, diphtheria, tetanus, pertussis, invasive disease Haemophilus influenzae type B and hepatitis B – caused the child’s autism. The decision was based on an expert’s opinion that made several extremely problematic arguments, arguments that go against the scientific evidence. It has been criticized by the Italian scientific community (translated summary, pdf), and is, apparently, being appealed.

This post explains the reasoning of the decision, and why it is fundamentally flawed.”

This post, written with Arthur Caplan, responds to Alan Phillips’ claim that a law proposed in New York, a law that would allow teen agers to consent to certain vaccines – the HPV and Hepatitis B vaccine – without needing parental permission is unconstitutional and illegal. The post explains why the law is both legal and justified.

The Maine Coalition for Vaccine Choice proposed a very problematic law that could mislead parents into not vaccinating because of false claims and would go against public policy. This post explains the problems with the law.